IGMPI India

Nova products issued a nationwide voluntary recall of 7 brands of dietary supplements due to undeclared pharmaceutical ingredients. The company recalled African Black Ant (Lot# 2006-000926), Black Ant (Lot# 2006-3627878), XZen Gold (Lot# 130310GL), ZXen Platinum (Lot# 130520PL), XZen 1200 (Lot# 13051012), XZone Gold (Lot# 131110GL), XZone 1200 (Lot# 13071012) and Mojo Risen (Lot# 10081359) at the retail level.

The lot number can be identified on the back or side of each product. The laboratory analysis of these products by FDA has revealed that they contain undeclared amounts of Sildenafil and Tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction that are not mentioned on the label. These undeclared ingredients pose a threat to consumers because they can interact with nitrates found in some prescription drugs (such as nitroglycerin), resulting in decreased blood pressure.

Prescription drugs containing nitrates are often prescribed for individuals with diabetes, high blood pressure, high cholesterol, or heart disease. These products may also cause side effects such as headaches and flushing. These products are marketed as dietary supplements for sexual enhancement and packaged in blister packs, envelopes, bottles, and/or boxes distributed to consumers nationwide at retail stores. The company has discontinued distribution and sales of these products.